A Home Exercise Program for Women With Infants & Young Children (Mama Move)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by University of Hawaii
Sponsor:
Collaborator:
Klein Buendel, Inc.
Information provided by (Responsible Party):
University of Hawaii
ClinicalTrials.gov Identifier:
NCT01738984
First received: November 28, 2012
Last updated: April 16, 2013
Last verified: April 2013
  Purpose

This Phase II Small Business Technology Transfer(STTR) project will develop and test the effectiveness of an interactive web program optimized for use on a Internet connected television(TV), titled Moms Exercising or (MomZing) that is designed specifically for women with infants 2-8 months old. Moms will select from a menu of 98, 10-minute exercise videos demonstrating yoga, aerobics, and strengthening exercises. They select and sequence together exercise videos personalized to their fitness level, form of exercise, and the choice to actively exercise with her baby or alone. The primary health goal of the MomZing Program is to increase home-based moderate to vigorous physical activity in new mothers and to maintain their exercise increases over time as their baby grows.

The investigators hypothesize that women that use the MomZing Program will have greater increases in physical activity and fewer will return to cigarette smoking or alcohol use, compared to women who use a standard "mommy and me" exercise DVD.


Condition Intervention Phase
MomZing Web Program
Standard Exercise DVD
Behavioral: MomZing Web Program
Behavioral: Standard Exercise DVD
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Home Exercise Program for Women With Infants & Young Children

Resource links provided by NLM:


Further study details as provided by University of Hawaii:

Primary Outcome Measures:
  • Minutes per week of moderate-to-vigorous physical activity [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
    physical activity will be obtained via online surveys


Secondary Outcome Measures:
  • number of cigarettes smoked per day [ Time Frame: baseline, 12 weeks ] [ Designated as safety issue: No ]
    cigarettes smoked before pregnancy and at baseline and 12 weeks will be collected via survey


Other Outcome Measures:
  • number of drinks per day of alcohol [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]
    alcohol intake measured via online surveys


Estimated Enrollment: 572
Study Start Date: January 2013
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MomZing Web Program
Features include selection one to three 10-minute videos demonstrating yoga, aerobics, and strengthening, specifically designed for mothers with infants 2 to 8 months of age. Women will sequence together videos personalized to their fitness level, preference for exercise type, and a choice to actively exercise with her baby or alone. Exercises with a baby will be tailored to the infant's weight and include interactions that promote cognitive development and mother-child bonding.
Behavioral: MomZing Web Program
Online web platform that is accessed via a television connected to internet
Experimental: Standard exercise DVD
Exercise DVD that demonstrates yoga or strengthening exercises a mother can perform with her infant.
Behavioral: Standard Exercise DVD
Standard exercise DVD that demonstrates exercises a women does with an infant.

Detailed Description:

Becoming a mother is a significant transition in a woman's life, and while this is a positive experience for many, there can be significant decreases in healthful behaviors such as physical activity and increases in unhealthy behaviors including sleep deprivation, stress, and depressive symptoms. Increasing postpartum physical activity can have multiple health benefits including risk reduction for chronic diseases like diabetes and cardiovascular disease, and improvement in psychological health including decreased stress and depressive symptoms. Improvements in mental health outcomes can prevent substance use since psychological stress is a risk factor for substance use and abuse. The postpartum period also represents a critical period to prevent a return to substance use, including tobacco and alcohol.

This Small Business Technology Transfer(STTR)- Phase II project will develop and test an interactive web-enabled television program, titled Mothers Exercising or ("MomZing). Features include the ability to select one to five 10-minute videos demonstrating yoga, aerobics, and strengthening exercises for mothers with infants 2 to 8 months of age. Women will select and sequence together videos personalized to their fitness level, preference for exercise type, and the choice to actively exercise with her baby or alone. Exercises with a baby will be tailored to the infant's weight and include interactions that promote cognitive development and mother-child bonding. MomZing is designed for viewing on a television taking advantage of new technologies that allow viewers to watch streaming video (including movies) from the internet on a television. The television can also be connected to the internet via a web-enabled console such as an internet-connecting device.

The primary goal of the MomZing web-enabled Program is to increase home-based moderate to vigorous physical activity in new mothers. Phase II activities will include: 1) programming the MomZing multimedia web enabled Program, a recruitment website, and online survey; 2) producing 98,10-minute video segments showing women exercising with or without an infant; 3) conducting iterative usability testing of the features and content of the Program; and, 4) conducting a randomized trial of the efficacy of the Program with 572 new mothers recruited from across the U.S. New mothers will be randomly assigned to receive either the MomZing web-enabled TV Program or a standard exercise DVD designed for new mothers. The primary outcome will be minutes per week of leisure-time moderate to vigorous physical activity measured at baseline, 4 and 12 weeks. Secondary outcomes include changes in fatigue, sleep, depressive symptoms, tobacco and alcohol use at 12 weeks. Process evaluation will also determine extent to which the technology is utilized (frequency of use and time per access) over 12 weeks in both conditions. We will investigate whether key demographic (i.e., weight of infant, number of children) physiological (i.e., body mass index), and lifestyle factors (sleep quality, fatigue) act as mediators or moderators of any change in physical activity.

The MomZing Program will allow Moms to tailor a range of exercise options to meet their needs and those of their infant. As their infant grows and progresses through different cognitive and developmental stages the Program can grow with them, allowing the Mom to change her preferences unlike any exercise multimedia(DVD or website) currently available on the market.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • woman aged 18-45 who has an infant 2-8 months old (who weighs 11-22 lbs)
  • live in one of the 50 states in US
  • have broadband, high speed wireless internet access at home
  • have high definition, flat screen TV at home
  • have DVD player at home
  • sedentary (<30 minutes of exercise per week)
  • BMI between 17-40
  • healthy woman
  • healthy infant
  • likes to learn about new technology

Exclusion Criteria:

  • woman has health problems: pregnant or planning to become pregnant in next 3 months, dizziness/loss of consciousness, bone/joint problems that would be made worse by exercise, cancer, coronary heart disease (chest pain),insulin dependent diabetic, exercise -induced asthma or other atherosclerotic cardiovascular diseases, on medication for heart condition/high blood pressure, doctor has limited the amount of physical exertion/exercising.
  • Baby has health problems -a chronic illness/disorder that would prevent mother from holding or lifting him/her in her arms while exercising
  • Woman cannot read/write English
  • woman unable or unwilling to connect a device to her television at home to link it to her home's wireless network
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01738984

Contacts
Contact: Cheryl L Albright, PhD, MPH 808 956 9716 cherylal@hawaii.edu
Contact: Kara N Saiki, MPH 808 956 9781 knsaiki@hawaii.edu

Locations
United States, Hawaii
University of Hawaii at Manoa Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Cheryl L Albright, PhD, MPH    808-956-9716    cherylal@hawaii.edu   
Contact: Kara Saiki, MPH    808 956 9781    knsaiki@hawaii.edu   
Sub-Investigator: Andrea Dunn, PhD         
Cheryl Albright, PhD, MPH Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Cheryl L Albright, PhD, MPH    808-956-9716    cherylal@hawaii.edu   
Contact: Kara Saiki, MPH    8089569781    knsaiki@hawaii.edu   
Sponsors and Collaborators
University of Hawaii
Klein Buendel, Inc.
Investigators
Principal Investigator: Cheryl L Albright, PhD, MPH University of Hawaii
  More Information

Additional Information:
No publications provided

Responsible Party: University of Hawaii
ClinicalTrials.gov Identifier: NCT01738984     History of Changes
Other Study ID Numbers: 9R42 DA031402
Study First Received: November 28, 2012
Last Updated: April 16, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Hawaii:
exercise
video
DVD
mother
infant

ClinicalTrials.gov processed this record on July 20, 2014